[Ip-health] NYT Opinion: It’s Time to Trust China’s and Russia’s Vaccines

K.M. Gopakumar kumargopakm at gmail.com
Sat Feb 6 08:51:50 PST 2021


   It’s Time to Trust China’s and Russia’s Vaccines

They, too, work, and they can help fill shortages everywhere.

By Achal Prabhala and Chee Yoke Ling



Mr. Prabhala is an Indian public health activist promoting wider
distribution of Covid-19 vaccines. Ms. Chee, a Malaysian public interest
lawyer, worked for a decade on improving access to medicines in China.



Feb. 5, 2021



While the richest countries in the world are grappling with shortages of
Covid-19 vaccines, some of the poorest worry about getting vaccines at all.
Yet a solution to both problems may be hiding in plain sight: vaccines from
China and Russia, and soon, perhaps, India.



Chinese and Russian vaccines were initially dismissed in Western and other
global media, partly because of a perception that they were inferior to the
vaccines produced by Moderna, Pfizer-BioNtech or AstraZeneca. And that
perception seemed to stem partly from the fact that China and Russia are
authoritarian states.



But evidence has been accumulating for a while that the vaccines from those
countries work well, too. The leading medical journal The Lancet published
this week interim results from late-stage trials showing that Sputnik V,
the Russian vaccine, had an efficacy rate of 91.6 percent. Those confirmed
findings released in mid-December by the vaccine’s developers, the Gamaleya
Center and the Russian Direct Investment Fund.



The United Arab Emirates, Bahrain, Egypt, Jordan, Iraq, Serbia, Morocco,
Hungary and Pakistan have approved the Sinopharm vaccine from China; as of
mid-January, 1.8 million people in the U.A.E. had received it. Bolivia,
Indonesia, Turkey, Brazil and Chile have approved and begun to roll another
Chinese vaccine, from Sinovac. Sputnik V will be distributed in more than a
dozen countries in Europe, the Middle East, Africa and Latin America.



When those countries vetted these vaccines, they made informed decisions,
based on evidence about safety and efficacy released by the Chinese and
Russian manufacturers — much of it also published
<https://www.thelancet.com/article/S1473-3099(20)30843-4/fulltext> in
peer-reviewed scientific journals like The Lancet
<https://www.thelancet.com/article/S0140-6736(20)31866-3/fulltext> and JAMA
<https://jamanetwork.com/journals/jama/fullarticle/2769612> — or after
running independent trials of their own. To assume otherwise is to doubt
the ability or integrity of these governments, some of which have health
regulatory systems on par with those in the United States or Europe.



In the face of major vaccine shortages and delivery delays, France, Spain
and Germany are now beginning to talk about possibly placing orders for the
Chinese and Russian vaccines. Semi-desperation, it seems, has finally
prompted them to call out “prejudice” against non-Western vaccines.



But the skepticism endures. There is suspicion of the Russian vaccine in
Iran, of the Chinese vaccines in Pakistan, and of both in Kenya and South
Africa. A recent YouGov poll asked 19,000 people in 17 countries if they
thought “more positively or negatively” about vaccines developed in which
of those countries: Russia, China and India ranked lowest (except for Iran).



To some extent this is understandable. China’s and Russia’s self-serving
propaganda campaigns touting their respective vaccines only increased
wariness, especially abroad.



China and Russia also started inoculating some of their citizens last year
without efficacy results from late-stage, or Phase 3, clinical trials. (The
Pfizer-BioNTech and Moderna vaccines were approved in the United States
after interim results from Phase 3 trials.) India has done the same
recently with Covaxin, a vaccine developed by Bharat Biotech, causing a
national furor.

All three governments have defended these actions as emergency measures
necessary to accelerate the production and distribution of vaccines. That
explanation may seem inadequate to some, but doing this is legal, and
regulators in the West also cut corners for the same reason (though with
more transparency).



And now there are significant data about the reliability of the Chinese and
Russian vaccines. (It’s still too early to tell for Covaxin.) Trial results
in the U.A.E. in early December placed the efficacy of the Sinopharm
vaccine at 86 percent; others, in China, at 79 percent.



A note, too, about what these efficacy numbers really measure and mean.
Confusion over that has created doubts about vaccines — though about some
vaccines more than others.



Take Sinovac’s, and what appear to be conflicting results about its
performance: 91 percent efficacy in trials in Turkey, 65 percent in trials
in Indonesia and 50.4 percent in trials in Brazil. That last finding
promptly made international headlines, even though researchers at the
Butantan Institute, the state-run center in São Paulo that conducted those
trials, pointed out at the same time that the vaccine had scored a 78
percent efficacy rate in preventing mild-to-severe cases of Covid-19.



We talked to Ricardo Palacios, the clinical research medical director at
the Butantan Institute, in late January, and he told us that the trials had
deliberately been designed as a “stress test.” They were conducted
exclusively among “health care workers directly taking care of Covid-19
patients,” he said. (The Pfizer-BioNTech and Moderna vaccine trials
included some health care workers and other individuals at high risk, but
not just.) And when you study a pool of subjects with much greater exposure
to infection, a vaccine is likely to appear to perform less well. The
Butantan Institute’s trials also defined what counted as a symptom of
Covid-19 much more broadly than did other trials.



The protocols for trials vary, in other words, even for the same vaccine.
Considering that, now imagine the potential for differences among results
from trials for various vaccines — differences that may reveal as much
about the trials’s designs as the vaccines’ performance.



No doubt, more information about the Chinese and Russian vaccines must be
released to the public, but the same still goes to some extent for the
leading Western vaccines. Not all the details or raw data for trials of the
Pfizer-BioNTech and Moderna vaccines have been made available, not even to
researchers.



So how can these vaccines be made desirable to more of the people who need
them? One way would be to subject them to a formal assessment by an
international organization with technical expertise. The problem currently
is that the World Health Organization’s rules for certifying vaccines are
themselves skewed in favor of rich, essentially Western, states.



The W.H.O. maintains a list of “stringent regulatory authorities” it trusts
for quality control — all are European countries except for Australia,
Canada, Japan and the United States. For the rest of the world, the W.H.O.
runs a service called prequalification. In theory, this is a way by which
vaccines from, say, China or Russia could be placed on an equal footing
with vaccines from the West. In reality, it’s an onerous and time-consuming
process.



When a vaccine is developed in and approved by a country on the W.H.O.’s
trusted list, the organization usually relies on that assessment to quickly
sign off. But when a vaccine maker anywhere else applies for
prequalification, the W.H.O. conducts a full evaluation from scratch,
including a physical inspection of the manufacturing facilities.



The W.H.O. ap Advertisement

Continue reading the main story



The fact is that no Covid-19 vaccine has been developed or released as
transparently as it should have been. And while China and Russia may have
botched their rollouts more than some Western companies, that doesn’t
necessarily mean their vaccines are shoddy.



The mounting evidence showing that the Chinese and Russian vaccines are
reliable should be taken seriously, and fast, especially considering supply
issues throughout the world.



Most vaccines produced in the West have already been bought up by rich
countries: as of early December, all of Moderna’s vaccines and 96 percent
of Pfizer-BioNTech’s, according to the People’s Vaccine Alliance, a
coalition of organizations calling for wider and fairer access to vaccines
worldwide.



Gavi, the Vaccine Alliance has some Western vaccines reserved. But by our
tally of its supply data, as of this week, it estimated being able to ship
during the first quarter of this year only between 110 million and 122
million doses from AstraZeneca and a mere 1.2 million doses from
Pfizer-BioNTech — for all 145 of the countries that have signed up with
Gavi to obtain Covid-19 vaccines.



What’s more, most big pharmaceutical companies in the West have resisted
licensing their vaccines to non-Western manufacturers, and several wealthy
countries are blocking a proposal by India and South Africa that the World
Trade Organization temporarily suspend some intellectual property
protections for Covid-19-related vaccines and treatments.



On the other hand, according to our latest analysis of data provided by the
analytics firm Airfinity, Sinovac has already signed deals to export this
year more than 350 million doses of its vaccine to 12 countries; Sinopharm,
around 194 million doses to 11 countries; Sputnik V, about 400 million
doses to 17 countries. All three manufacturers have stated publicly that
they will have the capacity to produce up to 1 billion doses each in 2021.
And all three have licensed their vaccines to local manufacturers in
several countries.proved the Pfizer-BioNTech vaccine at the end of 2020
less than two months after the makers applied for consideration, and it is
expected to decide on the Moderna and AstraZeneca vaccines this month. The
Chinese and Russian vaccines are still waiting in line, even though the
review processes for those were initiated earlier.



In the course of reviewing the Pfizer-BioNTech vaccine, the W.H.O. worked
closely with the European Medicines Agency, and approved it about 10 days
after the E.M.A. had. There is no reason the W.H.O., while maintaining its
standards, couldn’t also collaborate with health regulators in other
countries to help local vaccine manufacturers get through the vetting
process. It must urgently give all vaccine-producing countries the
attention they deserve.



Some doctors and activists have put forward proposals to increase the
delivery worldwide of vaccines produced in the West. These calls are
well-intentioned, but they, too, assume that vaccines from Western
countries are the only ones worth having — and waiting for.



There is a simpler solution, already at hand: It’s time to start trusting
other countries’ vaccines.



Achal Prabhala is the coordinator of the AccessIBSA project, which
campaigns for access to medicines, and a fellow of the Shuttleworth
Foundation. Chee Yoke Ling is the executive director of Third World
Network, an international policy research and advocacy organization
headquartered in Penang, Malaysia.



Link:
https://www.nytimes.com/2021/02/05/opinion/covid-vaccines-china-russia.html


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